3 European Pharmaceutical & Device Packaging and Labelling Regulations you need to know


1st January, 1970

3 European Pharmaceutical & Device Packaging and Labelling Regulations you need to know

In this ever-changing world we live in, it’s important to never forget the legislations that help save lives, and this can’t be emphasised enough with the design of pharmaceutical and device products. New regulations are created to ensure consumer safety and they are updated with the introduction to new innovative technologies. Here, we take a look at three regulations that concern the packaging and labelling of pharmaceutical and device products.  

Medical Device Regulation

The Medical Device Regulation (MDR) ensures high standards of quality and safety for medical devices being produced in or supplied to Europe. While the regulation came into effect on the 25th May last year, there is a transition period lasting until the 26th of May 2020 when it becomes mandatory across the EU. Throughout the next two years, devices can be placed on the market under the previous EU Directives and the manufacturers need to meet those requirements within that time frame.

Falsified Medicines Directive

The purpose of the Falsified Medicines Directive (FMD) is to protect patients by reducing the possibility of counterfeit medicines entering the supply chain. It will empower manufacturers, wholesalers, distributors as well as all patient suppliers to verify the authenticity of a medicinal product, identify individual packs, and check whether the outer packaging of medicines has been tampered with. The FMD won’t be operational until February 2019.

Identification of Medicinal Products

Identification of Medicinal Products (IDMP) facilitates the actions of medicines and regulatory agencies worldwide for a variety of activities, including the development, registration, and lifecycle management of medicinal products. It’s comprised of five International Organization for Standardization (ISO) norms on the use, consumption and packaging of drugs. This includes regulated information on substances, medicinal product information, pharmaceutical product information and more. Although this came into effect in July 2016, this year the products will be enforced.

Would you like to find more about regulations that are shaping pharma and medical devices packaging design? This September, the Pharma Packaging and Labelling conference will provide an opportunity for you to review these legislations, their challenges and strategic developments in this industry. Now more than ever, it’s important pharmaceutical companies are informed of these initiatives and soon. For more information, please visit http://www.arena-international.com/pharmapackagingeurope/ or alternatively email us at: events@arena-international.com


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